Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus

A Multicenter, Randomized, Open-label Study to Compare the Development of Liver Fibrosis at 12 Months After Transplantation for Hepatitis C Cirrhosis in Patients Receiving Either Cyclosporine Microemulsion or Tacrolimus

Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver. The aim of this study was to see if the frequency of liver fibrosis was different with cyclosporine microemulsion than tacrolimus

Inclusion criteria

• Reason for transplant is end-stage liver disease due to hepatitis C cirrhosis
• Patients receiving a first liver transplant from a deceased or living donor
• Patients in whom biopsies will be possible

Exclusion criteria

• Recipients of a liver from an hepatitis C virus positive (HCV+), human immunodeficiency virus positive (HIV+) or hepatitis B virus positive (HBV+) donor
• Patients with any severe coexisting disease or suffering any unstable medical condition or co-infected with HBV or HIV
• Patients with co-existing alcoholic disease who have not been abstinent for at least 6 months
• Transplanted for liver cancer exceeding a pre-defined size
• Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply